a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically proven initial diagnosis of prostate adenocarcinoma

• Priory treated and controlled primary tumor

• Biochemical recurrence defined by prostate-specific antigen (PSA) values \>0,2 ng/ml (i.e., two consecutive increases) following radical prostatectomy + postoperative radiotherapy and a PSA value of 2 ng/ml above the nadir after high-dose RT.

• Oligorecurrent disease defined as a maximum of 5 extracranial metastases in any organ, diagnosed on PSMA PET-CT or PSMA PET-MRI reported according to the E-PSMA consensus guidelines for interpretation of PSMA-PET (26). Nodal (N1) disease can be included only when accompanied by M1a-c disease, provided that the total number of spots does not exceed 5.

• Serum testosterone level within normal range.

• WHO performance 0-2

• Age \>= 18 years old

• Absence of psychological, sociological or geographical condition potentially hampering compliance with study protocol.

• Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board.

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures

• 2\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.

Locations
Other Locations
Belgium
University Hospitals Leuven
RECRUITING
Leuven
Contact Information
Primary
Kato Rans, MD
kato.rans@uzleuven.be
003216340110
Backup
Gert De Meerleer, MD, PhD
gert.demeerleer@uzleuven.be
003216347600
Time Frame
Start Date: 2022-04-20
Estimated Completion Date: 2032-04-25
Participants
Target number of participants: 873
Treatments
Active_comparator: MDT alone
Metastasis-directed therapy alone
Experimental: MDT + 1 month of ADT
Metastasis-directed therapy plus one month of androgen deprivation therapy (gosereline 3.6 mg sc, leuproreline 7.5 mg sc, triptoreline 3.75 mg im)
Experimental: MDT + 6 months of ADT + anzalutamide
Metastasis-directed therapy plus 6 months of androgen deprivation therapy (gosereline 3.6 mg sc 1x/month or gosereline 10.8 mg sc or leuproreline 7.5 mg sc 1x/month or leuproreline 45 mg sc or triptoreline 3.75 mg im 1x/month or triptoreline 11.5 mg im 1x/3months or triptoreline 22.5 mg im) and enzalutamide (4 x 40 mg each day during 6 months )
Related Therapeutic Areas
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov

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